BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FEMORAL 8MM OFFSET AIMER

    MDR report key: 2781181 · Received October 10, 2012

    Report

    Report Number
    1221934-2012-00261
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    NBH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK RECEIVED AND VISUALLY EVALUATED THE 4 COMPLAINT DEVICES REPORTED IN THIS FILE. IT IS NOTED THAT OUTSIDE OF SIGNS OF USAGE, THE DEVICES APPEAR IN GOOD CONDITION, NO DAMAGE AND NO ANOMALIES; WE COULD NOT DETECT ANY SIGNS OF FRICTION WEAR OF CONTACT. THE DEVICES ARE REPORTED TO BE OVER 10 YEARS OLD AND SO HAVE BEEN IN USE FOR QUITE SOME TIME WITHOUT ANY REPORTED ISSUES. WE CANNOT TELL ANYTHING FROM THIS. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFORMATION RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT. AWAITING DEVICE RETURN.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE, THE SURGEON OBSERVED METAL FILINGS EMANATING FROM 4 OFFSET FEMORAL AIMERS AND FALLING INTO THE JOINT SPACE. ALL OF THE DEBRIS WAS REMOVED FROM THE BODY AND THE PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PATIENT. THE COMPLAINT DEVICES ARE OVER 10 YEARS OLD. ALSO SEE ASSOCIATED MDRS 1221934-2012-00258, 1221934-2012-00259 AND 1221934-2012-00260.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK FEMORAL 8MM OFFSET AIMER ARTHROSCOPIC INSTRUMENTS NBH DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1